FDA UDI
In Commercial Distribution
🇺🇸 United States
CODMAN® BACTISEAL®
DI: 10381780537113
·
Model: NS5074
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CODMAN® BACTISEAL®
- Primary DI
- 10381780537113
- Version / Model
- NS5074
- Catalog Number
- NS5074
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-20
- Public Version
- 2
- Public Version Date
- 2025-03-24
- Public Version Status
- Update
- Public Device Record Key
- 1abb30d8-9d31-4a64-b0e5-6bebcc51dd5a
Device Description
CODMAN® BACTISEAL® Catheter MR Conditional Contents: Peritoneal Catheter 120cm (1)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JXG | Shunt, central nervous system and components | Neurology | 882.5550 | 2 |
| HCA | CATHETER, VENTRICULAR | Neurology | 882.4100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61159 | Peritoneal/atrial cerebrospinal fluid catheter | A flexible tube intended to be implanted as the distal component of a ventriculo-peritoneal/atrial shunt, to channel cerebrospinal fluid (CSF) to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where excess CSF causes elevated intracranial pressure (hydrocephalus). Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780537113 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Length | 120 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 81 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 81 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged, Keep away from sunlight